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Subsys sublingual

Important Note

Warnings
Uses
Side Effects
Precautions
Interactions
Overdose
Subsys sublingual Warnings

Fentanyl has a high risk for abuse and severe, possibly fatal, breathing problems. Do not use this product unless you have been regularly taking moderate to large amounts of narcotic pain medication. Otherwise, it may cause overdose (even death). The risk for harm is higher if you take the wrong dose/strength, or if you take it along with other drugs that might also affect breathing. It might also be higher when you start this medication and after a dose increase. Get medical help right away if you notice unusual slow/shallow breathing.

Carefully follow the specific directions for using fentanyl sublingual spray. Different forms of fentanyl (including lozenges, buccal tablets, patches) do not have the same effects at equal strengths and should not be substituted for each other. Tell your doctor or pharmacist of all medications that you use, especially of drugs that might affect breathing or that can affect how fentanyl works (see also Drug Interactions section). Do not start, stop, or change the dosage of any medicines you are using without your doctor's approval.

Keep this medicine in a safe place to prevent theft, misuse, or abuse. If a child accidentally uses or swallows this drug, get medical help right away.

Because of the risk of misuse, abuse, and overdose, you will need to register with a special distribution program before receiving your prescription. Only doctors and pharmacies enrolled in this program may prescribe or dispense this medication. Ask your doctor or pharmacist for details.

Subsys sublingual Uses

See also Warning section.

This medication is used to help relieve sudden (breakthrough) cancer pain in people who are regularly taking moderate to large amounts of narcotic pain medication. Fentanyl belongs to a class of drugs known as narcotic (opiate) analgesics. It works in the brain to change how your body feels and responds to pain.

This medication should not be used to relieve mild or short-term pain (such as due to headache/migraine, dental procedures, surgery).

How to use Subsys sublingual

See also Warning section.

Read the Medication Guide and the Instructions For Use Leaflet provided by your pharmacist before you start using fentanyl and each time you get a refill. Learn all preparation, usage, and disposal instructions. If you have any questions, ask your doctor or pharmacist.

Open the blister package with scissors right before using this medication. Swallow any saliva in your mouth. Spray the medication in your mouth underneath the tongue. Hold the medication under your tongue for 30 to 60 seconds. Do not spit out the medication or rinse out your mouth after using the spray.

Use this medication as directed by your doctor. If the pain is not relieved 30 minutes after using this medication, you may take another dose. Do not use more than 2 doses of this medication for each episode of breakthrough pain. Tell your doctor if you do not get pain relief within 30 minutes of using the second dose of this medication or if you have another episode of breakthrough pain within 4 hours of using this medication. You must wait at least 4 hours before using this medication again to treat another episode of breakthrough pain. Follow your doctor's instructions on taking another medication to treat the pain before you can use this medication again.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor will direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Do not increase your dose or use this drug more often or for longer than prescribed.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Pain medications work best if they are used when the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

You should continue to also take your long-acting narcotic medication as directed by your doctor. Other non-narcotic pain relievers (such as acetaminophen, ibuprofen) may also be prescribed with this medication. Ask your doctor or pharmacist if you have any questions about using fentanyl safely with other drugs.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Ask your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your pain persists or worsens, if you have more than 4 episodes of breakthrough pain daily, or if you need to use 2 doses of medication for each episode of pain.

Subsys sublingual Side Effects

Nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating, slow heartbeat.

Get medical help right away if you have any very serious side effects, including: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Subsys sublingual Precautions

Before taking fentanyl, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), sores/ulcers in the mouth, kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate), slow/irregular heartbeat, gallbladder disease, disease of the pancreas (pancreatitis).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and slow/shallow breathing.

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, use the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.

This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.

Subsys sublingual Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: certain pain medications (mixed narcotic agonist-antagonists such as pentazocine, nalbuphine, butorphanol), narcotic antagonists (such as naltrexone).

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

Other medications can affect the removal of fentanyl from your body, which may affect how fentanyl works. Examples include azole antifungals (such as itraconazole, ketoconazole), calcium channel blockers (such as diltiazem, verapamil), HIV protease inhibitors (such as nelfinavir, ritonavir), macrolide antibiotics (such as erythromycin), nefazodone, mifepristone, rifamycins (such as rifabutin), St. John's wort, certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and other narcotic pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain laboratory tests (including amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Subsys sublingual Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow breathing, slow heartbeat, loss of consciousness.

NOTES:

Do not share this medication with others. It is against the law and the medication may cause harm to others.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE:

Not applicable.

STORAGE:

Store at room temperature. Do not store in the bathroom. Do not open the blister package until ready for use. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Read the Instructions for Use Leaflet for details. You may also consult your pharmacist or local waste disposal company for more details.

Information last revised October 2013. Copyright(c) 2013 First Databank, Inc.

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